DETAILED ACTION
The Applicant’s response, received 13 February 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-6, 9-12, 16, and 18-22 are pending.
Claims 1-6, 9-12, 16, and 18-22 are rejected.
Priority
This application is a 371 of PCT/JP2019/029075, filed 24 July 2019.
Foreign Applications for which benefit of priority is claimed are:
JAPAN 2019-132300, filed 17 July 2019, and
JAPAN 2018-138662, filed 24 July 2018.
Therefore, the effective filing date of the claimed invention is 24 July 2018.
Drawings
The objection to the drawings in the Office action mailed 21 November 2025 is withdrawn in view of the replacement drawings received 13 February 2026.
The replacement drawings received 13 February 2026 are accepted.
Claim Interpretation
The claim interpretations under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, in the Office action mailed 21 November 2025 are maintained in view of the amendment received 13 February 2026, as noted below.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are:
an image acquirer, in claims 1 and 20;
an information acquirer, in claims 1, 11, and 20; and
an analyzer, in claims 1, 5, 6, 16, 18, and 19.
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description discloses a corresponding structure for:
an image acquirer, at ¶ [0037] of the Specification (a CCD or CMOS sensor); and at ¶¶ [0118] – [0120] of the Specification (exemplary hardware configuration);
an information acquirer, at ¶ [0036] of the Specification (e.g., a barcode reader); at ¶ [0052] of the Specification (e.g., a general-purpose computer); and at ¶¶ [0118] – [0120] of the Specification (exemplary hardware configuration); and
an analyzer, at ¶ [0052] of the Specification (e.g., a general-purpose computer); and at ¶¶ [0118] – [0120] of the Specification (exemplary hardware configuration).
If applicant does not intend to have these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
The objection to claim 3 in the Office action mailed 21 November 2025 is withdrawn in view of the amendment received 13 February 2026.
Claim Rejections - 35 USC § 112
The rejection of claims 1-12, 16, are 18-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 21 November 2025 is withdrawn in view of further consideration of claims 1 and 20. Specifically, claims 1 and 20 recite the limitation “a display that receives image information…and presents image information…,” which upon further consideration, is interpreted to be an active step and not an intended use.
Claim Rejections - 35 USC § 101
The rejection of claims 1-12, 16, and 18-22 under 35 U.S.C. 101 in the Office action mailed 21 November 2025 is maintained with modification in view of the amendment received 13 February 2026.
The rejection of claims 7 and 8 is withdrawn in view of the cancellation of these claims in the amendment received 13 February 2026.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 9-12, 16, and 18-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1-6, 9-12, 16, 18, 19, and 21 are directed to an information processing apparatus (i.e., a machine or a manufacture); and claims 20 and 22 are directed to a microscope system comprising an information processing apparatus (i.e., a machine or a manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
separates a first fluorescence signal and a second fluorescence signal from the image information in accordance with the information regarding the cell and the information regarding the fluorescent reagent (i.e., mathematical concepts); and
recognizes a region of intracellular structure included in the image information in accordance with a distribution of the first fluorescence signal and the second fluorescence signal in the image information (i.e., mental processes).
Independent claim 20 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
separating a first fluorescence signal and a second fluorescence signal from the image information in accordance with the information regarding the cell and information regarding the fluorescent reagent (i.e., mathematical concepts); and
recognizing a region of intracellular structure included in the image information in accordance with a distribution of the first fluorescence signal and the second fluorescence signal in the image information (i.e., mental processes).
Dependent claims 2-6, 9-12, 16, 18, 19, 21, and 22 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 2 further recites:
the first fluorescence signal includes an autofluorescence signal of the cell (i.e., mental processes); and
the second fluorescence signal includes a fluorescence signal of the fluorescence reagent (i.e., mental processes).
Dependent claim 3 further recites:
the cell includes a first autofluorescent component and a second autofluorescent component (i.e., mental processes);
the first fluorescence signal includes an autofluorescence signal of the first autofluorescent component (i.e., mental processes); and
the second fluorescence signal includes an autofluorescence signal of the second autofluorescent component (i.e., mental processes).
Dependent claim 4 further recites:
the fluorescence reagent includes a first fluorescence reagent and a second fluorescence reagent (i.e., mental processes);
the first fluorescence signal includes a fluorescence signal of the first fluorescence reagent (i.e., mental processes); and
the second fluorescence signal includes a fluorescence signal of the second fluorescence reagent (i.e., mental processes).
Dependent claim 5 further recites:
separates a third fluorescence signal from the image information in accordance with the information regarding the cell and the information regarding the fluorescence reagent (i.e., mathematical concepts); and
the third fluorescence signal includes an autofluorescence signal of the cell (i.e., mental processes).
Dependent claim 6 further recites:
analyze a fixation state of the cell in accordance with a component ratio between the autofluorescence signal of the first autofluorescent component and the autofluorescence signal of the second autofluorescent component (i.e., mental processes and mathematical concepts).
Dependent claim 9 further recites:
the information regarding the cell further includes information regarding a kind of tissue to be used, a kind of disease of a target, an attribute of a target person, and a lifestyle habit of the target person (i.e., mental processes).
Dependent claim 10 further recites:
the information regarding the fluorescence reagent includes spectrum information of a fluorescence component included in the fluorescence reagent (i.e., mental processes).
Dependent claim 11 further recites:
acquires the information regarding the cell in accordance with cell identification information capable of identifying the cell (i.e., mental processes); and
acquires the information regarding the fluorescence reagent in accordance with reagent identification information capable of identifying the fluorescence reagent (i.e., mental processes).
Dependent claim 12 further recites:
the reagent identification information is further capable of identifying a production lot of the fluorescence reagent (i.e., mental processes).
Dependent claim 16 further recites:
performs a subtraction process for image information of a different cell using the first fluorescence signal to extract the fluorescence signal from the image information of the different cell (i.e., mental processes and mathematical concepts).
Dependent claim 18 further recites:
performs separation in accordance with a result of machine learning performed using the first fluorescence signal and the second fluorescence signal after the separation, the image information used in the separation, the information regarding the cell, and the information regarding the fluorescence reagent (i.e., mental processes and mathematical concepts).
Dependent claim 19 further recites:
at least one of the first and second fluorescence signals includes an autofluorescence signal (i.e., mental processes);
the information regarding the fluorescence reagent includes a quantum yield, a fluorescent labeling ratio, and an absorption cross section or a molar absorption coefficient concerning the fluorescent reagent (i.e., mental processes); and
calculate at least one of the number of fluorescence molecules in the image information or the number of antibodies coupled to the fluorescence molecules using the image information from which the autofluorescence signal is removed and information regarding the fluorescence reagent (i.e., mental processes and mathematical concepts).
Dependent claim 21 further recites:
wherein the region of intracellular structure comprises cytoplasm, a cell membrane, or the nucleus of the cell (i.e., mental processes).
Dependent claim 22 further recites:
wherein the region of intracellular structure comprises cytoplasm, a cell membrane, or the nucleus of the cell (i.e., mental processes).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., the step of recognizing a region of intracellular structure included in the image information in accordance with a distribution of the first fluorescence signal and the second fluorescence signal in the image information, involves evaluating and comparing data), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., calculating separation processes, statistically or recursively analyzing the details of the calculated processes, and machine learning for separating the fluorescence signal and the autofluorescence signal, ¶ [0059] in the Specification; and also, e.g., ¶¶ [0061] – [0068] in the Specification) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-6, 9-12, 16, and 18-22 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
Dependent claims 2-4, 9, 10, 12, 21, and 22 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements in independent claim 1 include:
an information processing apparatus comprising;
an image acquirer (e.g., a CCD or CMOS sensor) that acquires image information of a cell stained by a fluorescent reagent (i.e., acquires data);
an information acquirer (e.g., a general-purpose computer) that acquires information regarding the cell and information regarding the fluorescent reagent (i.e., acquires data);
wherein the information regarding the cell includes an autofluorescent component included in the cell and spectrum information of the autofluorescent component,
wherein the autofluorescent component included in the cell includes FAD (flavin adenine dinucleotide),
wherein the autofluorescent component included in the cell includes Porphin;
an analyzer (e.g., a general-purpose computer); and
a display
that receives image information based on the first fluorescence signal or the second fluorescence signal from the analyzer (i.e., receives data) and presents image information to a user (i.e., outputs data).
The additional elements in independent claim 20 include:
a microscope system comprising:
an information processing apparatus including:
an image acquirer (e.g., a CCD or CMOS sensor) that acquires image information of a cell stained by a fluorescent reagent (i.e., acquires data);
an information acquirer (e.g., a general-purpose computer) that acquires information regarding the cell and information regarding the fluorescent reagent (i.e., acquires data),
wherein the information regarding the cell includes an autofluorescent component included in the cell and spectrum information of the autofluorescent component,
wherein the autofluorescent component included in the cell includes NADH (nicotinamide adenine dinucleotide reduction type),
wherein the autofluorescent component included in the cell includes FAD (flavin adenine dinucleotide),
wherein the autofluorescent component included in the cell includes Porphin;
a non-transitory computer-readable medium;
a processor; and
a display
that receives image information based on the first fluorescence signal or the second fluorescence signal from the analysis (i.e., receives data) and presents image information to a user (i.e., outputs data).
The additional elements in dependent claims 5, 6, 11, 16, 18, and 19 include:
an analyzer (e.g., a general-purpose computer) (claims 5, 6, 16, 18, and 19); and
an information acquirer (e.g., a general-purpose computer) (claim 11).
The additional elements of an information processing apparatus comprising an image acquirer (e.g., a CCD or CMOS sensor) (claims 1 and 20), an information acquirer (e.g., a general-purpose computer) (claims 1, 11, and 20), an analyzer (e.g., a general-purpose computer) (claims 1, 5, 6, 16, 18, and 19), a non-transitory computer readable medium (claim 20), a processor (claim 20), and a display (claims 1 and 20); invoke a computer and/or computer-related components merely as tools for use in the claimed process, such that they amount to no more than mere instructions to apply the exceptions using a generic computer (MPEP 2106.05(f)), and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (see MPEP 2106.04(d)(1)).
The additional elements of acquires data (claims 1 and 20); receives data (claims 1 and 20); and outputs data (claims 1 and 20); are merely pre-solution and/or post-solution activities used in the claimed process – nominal or tangential additions to the claims that do not meaningfully limit the claims, and therefore do not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
The additional element of a microscope system (claim 20) merely indicates a field of use or technological environment in which to apply a judicial exception, and therefore does not integrate the recited judicial exceptions into a practical application.
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and/or a field of use in which to apply a judicial exception; and as such, when all limitations in claims 1-6, 9-12, 16, and 18-22 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-6, 9-12, 16, and 18-22 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claims 2-4, 9, 10, 12, 21, and 22 do not recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1 and 20 and dependent claims 5, 6, 11, 16, 18, and 19 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of an information processing apparatus comprising an image acquirer (e.g., a CCD or CMOS sensor) (claims 1 and 20), an information acquirer (e.g., a general-purpose computer) (claims 1, 11, and 20), an analyzer (e.g., a general-purpose computer) (claims 1, 5, 6, 16, 18, and 19), a non-transitory computer readable medium (claim 20), a processor (claim 20), and a display (claims 1 and 20); and acquires data (claims 1 and 20); receives data (claims 1 and 20); and outputs data (claims 1 and 20); are conventional (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional element of a microscope system (claim 20) is conventional. Evidence for the conventionality is shown by:
Mansfield (Multiplex Biomarker Techniques. Methods in Molecular Biology, 2017 (First online 29 November 2016), Vol 1546, pp. 75-99, as cited in the Office action mailed 30 September 2024).
Mansfield reviews staining and multiplex image analysis methods that have been developed for phenotyping immune and other cells in formalin-fixed, paraffin-embedded (FFPE) tissue sections (Title; and Abstract); and shows a schematic of the workflow for a simultaneously labeled sample, involving staining, imaging, image analysis, and summary data analysis that further shows steps of tissue segmentation, cellular segmentation, and cellular phenotyping (page 78, Figure 1). Mansfield further shows that any color camera on a microscope can be used to take an image (page 81, para. 1) and that machine learning can be used to assess an image and segment it into morphologic regions (page 90, para(s). 3-4).
Therefore, when taken alone, all additional elements in claims 1-6, 9-12, 16, and 18-22 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-6, 9-12, 16, and 18-22 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant’s arguments/remarks received 13 February 2026 have been fully considered, but are not persuasive.
The Applicant states on page 9 (para. 5) of the Remarks that the interpretations under 35 U.S.C. 112(f) make clear that aspects of a processing systems are acknowledged to be recited by the claims, and as such, it appears that the claims are alleged to recite processes capable of being mental processes, and for clarity, the amendments to claims 1 and 20 explicitly recite processors.
These arguments/remarks are not persuasive, at least because claims can recite judicial exceptions (e.g., mental processes) even if they are claimed as being performed on a computer (MPEP 2106.04(a)(2)(III)(C)).
The Applicant states on page 9 (para. 6) of the Remarks that with regard to any allegation that the claimed elements can be performed by a human and are, therefore, abstract ideas, the Applicant first refers to Example 29 of the USPTO Subject Matter Eligibility guidance issued between December 16, 2014 and December 15, 2016, and further states that the analysis for claim 1 of Example 29 clarifies that claim 1, reciting obtaining a plasma sample and detecting whether JUL-1 is present in the plasma sample, is not directed to a judicial exception to patentable subject matter at all. The Applicant further states on page 10 (para. 1) that similarly, instant claim 1, for example, recites one or more processors that “acquires image information, including an image…predicts a first fluorescence signal in the image based on” the image information and “extracts a second fluorescence signal by removing the first fluorescence signal from the image information to visualize an antigen in the specimen.” The Applicant further states that these elements do not recite a mental process of considering data, as alleged, and further states that a person cannot mentally consider data to obtain the claimed image information and modify aspects of the image information based on a prediction, e.g., as claimed, and thus, the eligibility analysis should end at Prong 2A, as in Example 29 (claim 1) and the recited claims should be deemed patent eligible.
These arguments are not persuasive, because first, with regard to the Applicant’s attempt to analogize instant claim 1 to hypothetical claim 1 of Example 29, the proper legal basis for construing the scope of the claims is not by analogizing them to USPTO training examples, but by interpreting the plain meaning of the claim language in light of the specification. As noted at Eligibility Step 2A Prong One in the rejection above, by the plain meaning of the claim terms, read in light of their corresponding descriptions in the specification, the instant claims 1 and 20 recite mathematical concepts and mental processes capable of being performed in the human mind with the aid of a pencil and paper. Second, the Eligibility Examples are hypothetical and only intended to be illustrative of the claim analysis performed using MPEP 2106, and of the particular issues noted in each Example, and therefore, the Examples should be interpreted based on the fact patterns set forth in a particular Example, as other fact patterns (e.g., the instant claims) may have different eligibility outcomes. Third, claim 1 of hypothetical Example 29 recites a method comprising two steps: (a.) obtaining a plasma sample from a human patient; and (b.) detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody. As noted in the corresponding analysis of the hypothetical claim limitations recited in claim 1 of Example 29, the limitations recited at steps a. and b. are additional elements, and not judicial exceptions (i.e., mental processes, mathematical concepts, or laws of nature), at least because hypothetical claim 1 recites steps of obtaining a plasma sample from a human patient (i.e., an additional element) and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody (i.e., an additional element). In contrast, instant claims 1 and 20 recite limitations at least involving operations on image data (i.e., judicial exceptions), as noted in the above rejection. Fourth, and as also noted in the above rejection, the claimed limitations that recite elements of the claimed system that acquire data are identified as additional elements, and not identified as steps performed in the human mind.
The Applicant states on page 10 (para. 2) of the Remarks that even if Prong 2B is reached, Example 4 of the USPTO Subject Matter Eligibility guidance indicates that the claimed invention should be found patent eligible, and further states that according to the analysis of Example 4, performing mathematical operations on a computer alone is not what the claims are directed to, and instead, the existing global positioning technology is improved. The Applicant further states (para. 3) that similarly, in the present case, the technology of immunofluorescence staining to visualize an antigen is improved by the claimed invention, and further states that specifically, as noted at paragraph [0052] of the published application, the inventors have found that the spectrum of autofluorescent components remains unvaried while the overall spectrum differs based on the specimen, and thus, as recited in claim 1, e.g., the claimed invention includes one or more processors that “predicts a first fluorescence signal in the image based on the information regarding the specimen and the information regarding the fluorescence reagent, and extracts a second fluorescence signal by removing the first fluorescence signal from the image information to visualize an antigen in the specimen.” The Applicant further states (para. 4) that under MPEP 2106.04, the claims properly cover “a particular solution to a problem or a particular way to achieve a desired outcome” rather than merely claiming the idea of a solution or outcome.
These arguments are not persuasive, because first, the claims do not actually recite the limitation “predicts a first fluorescence signal…” (emphasis added). Second, with regard to the Applicant’s attempt to analogize the instant claims to hypothetical Example 4, the Eligibility Examples are hypothetical and only intended to be illustrative of the claim analysis performed using MPEP 2106, and of the particular issues noted in each Example, and therefore, the Examples should be interpreted based on the fact patterns set forth in a particular Example, as other fact patterns (e.g., the instant claims) may have different eligibility outcomes, as noted in the above rejection. Third, regarding the Applicant’s argument that “the claims properly cover ‘a particular solution to a problem or a particular way to achieve a desired outcome’ rather than merely claiming the idea of a solution or outcome,” the MPEP at 2106.04(d) states that a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, and further states that evaluating integration into a practical application requires (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I at 2106.04(d) of the MPEP, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h). In the case of the analysis of the instant claims, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and/or a field of use in which to apply a judicial exception; and as such, when all limitations in claims 1-6, 9-12, 16, and 18-22 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-6, 9-12, 16, and 18-22 are directed to an abstract idea, as noted in the above rejection.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4, 7, 16, 20, 21, and 22 under 35 U.S.C. 102(a)(1) as being anticipated by Levenson et al. in the Office action mailed 21 November 2025 is withdrawn in view of the amendment received 13 February 2026.
Claim Rejections - 35 USC § 103
The rejection of claims 5 and 8 under 35 U.S.C. 103 as being unpatentable over Levenson et al. as applied to claims 1-4, 7, 16, 20, 21, and 22 in the rejection under 35 U.S.C. 102(a)(1) above, and further in view of Laiho et al. in the Office action mailed 21 November 2025 is withdrawn in view of the amendment received 13 February 2026.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Levenson et al. as applied to claims 1-4, 7, 16, 20, 21, and 22 in the rejection under 35 U.S.C. 102(a)(1) above, and further in view of Shipitsin et al. in the Office action mailed 21 November 2025 is withdrawn in view of the amendment received 13 February 2026.
The rejection of claims 18 and 19 under 35 U.S.C. 103 as being unpatentable over Levenson et al. as applied to claims 1-4, 7, 16, 20, 21, and 22 in the rejection under 35 U.S.C. 102(a)(1) above, and further in view of Bogh et al. in the Office action mailed 21 November 2025 is withdrawn in view of the amendment received 13 February 2026.
The Applicant’s amendment received 13 February 2026 has been fully considered, however after further consideration, new grounds of rejection are raised under 35 U.S.C. 103 in view of the amendment.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 16, 20, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson et al. (“Multispectral imaging in biology and medicine: slices of life.” Cytometry Part A: the Journal of the International Society for Analytical Cytology, 2006, vol. 69(8): pp. 748-758, as cited in the Office action mailed 21 November 2025) and Croce et al. (“Autofluorescence Spectroscopy for Monitoring Metabolism in Animal Cells and Tissues.” In: Pellicciari, C., Biggiogera, M. (eds) Histochemistry of Single Molecules. Methods in Molecular Biology, 2017, vol. 1560. Humana Press, New York, NY, pp. 15-43, newly cited).
Independent claims 1 and 20 are broadly directed to a system for acquiring image information of a cell stained by a fluorescent reagent, acquiring and analyzing information regarding the specimen and information regarding the reagent, and separating fluorescence signals based on the information regarding the specimen and the information regarding the reagent.
Dependent claims 2-4, 16, and 21-22 further define aspects of the fluorescence signals and reagents and further defines characteristics of the acquired image.
Levenson et al. discusses multispectral imaging (MSI) in biology and medicine, and shows that MSI, which spectrally characterizes and computationally eliminates autofluorescence, enhances the signal-to-background dramatically, revealing otherwise obscured targets (Abstract), e.g., single cell multiplexed imaging using spatially overlapping chromogens in brightfield (page 750, col. 1).
Croce et al. discusses autofluorescence spectroscopy for monitoring metabolism in animal cells and tissues (Abstract).
Regarding independent claims 1 and 20, Levenson et al. shows image acquisition using multispectral imaging systems that incorporate a liquid crystal tunable filter (LCTF) optically coupled to a CCD camera mounted onto a conventional fluorescence and brightfield microscope (page 750, col. 2); software for both the microscope and in-vivo imaging systems (page 757, col. 1); acquiring spectral datasets (page 750, col. 2); image analysis of spectral datasets (page 751, col. 1); fluorescein-labeled basal cells with an autofluorescence component and spectrum information of the autofluorescence component (FIG. 1); unmixing spectra of a fluorescein-labeled basal cells using the autofluorescence and computed fluorescein spectra to generate images to reveal the specific staining of the basal cells (FIG. 1); a spectral graph (FIG. 2(A)) indicating the spectra of the nuclei across emission wavelengths of dye used for labeling the intracellular structures (FIG. 2(B)); and a display for displaying the data (e.g., the aforementioned FIG. 2 shows that a display for displaying the images is part of the multispectral imaging systems).
Regarding independent claims 1 and 20, Levenson et al. does not show wherein the autofluorescent component included in the cell includes NADH (nicotinamide adenine dinucleotide reduction type), wherein the autofluorescent component included in the cell includes FAD (flavin adenine dinucleotide), wherein the autofluorescent component included in the cell includes Porphin.
Regarding independent claims 1 and 20, Croce et al. shows that excitation of biological substrates with light at suitable wavelength can give rise to a light emission in the ultraviolet (UV)-visible, near-infrared (IR) spectral range, called autofluorescence (AF). Croce et al. further shows that this is a widespread phenomenon, ascribable to the general presence of biomolecules acting as endogenous fluorophores (EFs) in the organisms of the whole life kingdom (Abstract). Croce et al. further shows that in the animal kingdom, AF studies at the cellular lever take advantage of the essential presence of NAD(P)H and flavins, and that additional EFs such as vitamin A, porphyrins, lipofuscins, proteins, and neuromediators can be detected in different kinds of cells and bulk tissues, and can be exploited as photophysical biomarkers of specific normal or altered morphofunctional properties, from the retinoid storage in the liver to aging processes, metabolic disorders or cell transformation processes (Abstract).
Regarding dependent claim 2, Levenson et al. further shows spectra of the autofluorescence (AF) signal; the mixed spectrum of fluorescein plus AF; and the computed fluorescein spectrum (FIG. 1(B)).
Regarding dependent claims 3 and 4, Levenson et al. further shows mice with two different species of autofluorescence and three subcutaneous fluorophore signals (FIG. 5).
Regarding dependent claim 16, Levenson et al. further shows subtracting a spectral background (e.g., autofluorescence) based on a specified intensity (page 751, col. 2).
Regarding dependent claims 21 and 22, Levenson et al. further shows identifying nuclear signals of cells after spectral unmixing (FIG. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Levenson et al. by incorporating endogenous fluorophores such as NADH (nicotinamide adenine dinucleotide reduction type), FAD (flavin adenine dinucleotide), and Porphin, as shown by Croce et al. and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Levenson et al. with the methods of Croce et al., because Croce et al. shows that endogenous fluorophores including NADH, FAD, and porphyrins can be exploited as photophysical biomarkers of specific normal or altered morphofunctional properties. This modification would have had a reasonable expectation of success given that both Levenson et al. and Croce et al. disclose methods for multispectral imaging of cells and tissue with regard to autofluorescence.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Levenson et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and further in view of Laiho et al. ("Two-photon 3-D mapping of ex vivo human skin endogenous fluorescence species based on fluorescence emission spectra." Journal of Biomedical Optics (2005), 10(2) 024016: pp. 1-10, as cited in the Office action mailed 21 November 2025).
Dependent claim 5 further defines the steps of processing the information in the autofluorescence signals in accordance with the information regarding the cell and the information regarding the fluorescence reagent.
Laiho et al. discusses an image-guided spectral analysis method to analyze the distribution of fluorophores in human skin (Title; and Abstract).
Regarding dependent claim 5, Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, does not show the analyzer further separates a third fluorescence signal from the image information in accordance with the information regarding the cell and the information regarding the fluorescence reagent; and the third fluorescence signal includes an autofluorescence signal of the cell (claim 5).
Regarding dependent claim 5, Laiho et al. shows an image-guided spectral analysis method to analyze the distribution of fluorophores in human skin to identify five factors (emphasis added) that contribute to most of the luminescence signals from the skin, including autofluorescent species tryptophan, NAD(P)H, melanin, and elastin located in various layers of the skin (Abstract; and FIG. 5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, by incorporating a method for identifying a third (or more) autofluorescence signal in a tissue, as shown by Laiho et al., and discussed above. One of ordinary skill in the art would have been motivated to combine the method of Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above with the method of Laiho et al., because tissue spectroscopy is a powerful method to identify endogenous fluorescence species (i.e., autofluorescence), the relative abundance of which is related to tissue physiological and pathological states, and Laiho et al. shows a method for obtaining the emission spectrum for four different layers within the skin that are representative of different structures. This modification would have had a reasonable expectation of success because both Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and Laiho et al. show methods for extracting spectral information using microscope-based image acquisition techniques.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Levenson et and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and further in view of Shipitsin et al. (Proteome Science, 2014, Vol. 12:40, pp. 1-13, as cited in the Office action mailed 30 September 2024).
Dependent claim 6 further defines aspects of the analyzation, including a fixation state of the cell in accordance with a component ratio between the autofluorescence signal of the first autofluorescent component and the autofluorescence signal of the second autofluorescent component.
Shipitsin et al. discusses an automated, integrated multiplex immunofluorescence in situ imaging approach that quantitatively measures protein biomarker levels and activity states in defined intact tissue regions where the biomarkers of interest exert their phenotype (Abstract).
Regarding dependent claim 6, Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, does not show the analyzer analyzes a fixation state of the cell in accordance with a component ratio between the autofluorescence signal of the first autofluorescent component and the autofluorescence signal of the second autofluorescent component.
Regarding dependent claim 6, Shipitsin et al. shows a tissue quality control procedure wherein sections from multiple FFPE blocks were stained, and then slides were examined under a fluorescence microscope, and based on staining intensities and autofluorescence, tissues were qualitatively graded into different categories (page 2, column 2, para. 2; and page 8, column 2, para. 4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, to incorporate a tissue quality control procedure utilizing fluorescence microscope. One of ordinary skill in the art would have been motivated to combine the method of Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above with the method of Shipitsin et al., because Shipitsin et al. shows grading the qualities of tissue sections from FFPE blocks based on staining intensities and autofluorescence, and further shows the use fluorescence staining intensities for controlling for specimen degradation and variability due to pre-analytic variation. This modification would have had a reasonable expectation of success because both Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and Shipitsin et al. show methods for fluorescence imaging analysis of tissue specimens.
Claims 9, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and further in view of Herzenberg et al. (US 2011/0282870, as cited in the Office action mailed 21 November 2025).
Dependent claims 9, 10, 11, and 12 further define aspects of the type of acquire information and how the acquired information is processed.
Herzenberg et al. discusses a system and method for selecting a multiparameter reagent combination and for the automated fluorescence compensation (Title; and Abstract).
Regarding dependent claims 9, 10, 11, and 12, Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, does not show the information regarding the cell further includes information regarding a kind of tissue to be used, a kind of disease of a target, an attribute of a target person, and a lifestyle habit of the target person (claim 9); the information regarding the fluorescence reagent includes spectrum information of a fluorescence component included in the fluorescence reagent (claim 10); the information acquirer acquires the information regarding the cell in accordance with cell identification information capable of identifying the cell and acquires the information regarding the fluorescence reagent in accordance with reagent identification information capable of identifying the fluorescence reagent (claim 11); or the reagent identification information is further capable of identifying a production lot of the fluorescence reagent (claim 12).
Herzenberg et al. shows a system and method for selecting an optimal multi-marker reagent combination for the identification and/or quantification of molecules in or on cells with or without reference to fluorescence or other properties of at least one fluorescent dye or other instrument-measurable atom or molecule associated directly or indirectly with the reagent combination (Abstract); and further shows a computer system comprising a personal reagent shopper program that is networked to data repositories and suppliers (FIGS 7A & 7B).
Regarding dependent claim 9, Herzenberg et al. shows a control panel for selecting antibodies reactive with different species (FIG. 2); indicating the markers (e.g., cell surface determinants) to be detected by the stain (para. [0059]; e.g., different tissues, cells, pathogens, and markers have unique components that require specific stains in order to be visualized, and thus, the systems as disclosed by Herzenberg et al. would comprise requiring information regarding a type of tissue, a type of disease, and an attribute and lifestyle habit of a subject in allowing the users of the system to indicate the markers of interest (particularly in the case of attempting to detect a suspected pathogen)).
Regarding dependent claim 10, Herzenberg et al. shows a system-defined criterion for spectral interaction, i.e., the range of the excitation maximum of a reagent of the reagent combination and/or the range of the emission spectrum of a reagent of the reagent combination (para. [0183]).
Regarding dependent claims 11 and 12, Herzenberg et al. shows steps for finding/filtering reagents by various attributes including by lot(s) (FIG. 5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, by incorporating methods for obtaining information regarding reagents for particular tissue and/or cell types, as shown by Herzenberg et al., and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, with the methods of Herzenberg et al., because Herzenberg et al. shows an automated system with capabilities for providing necessary information regarding reagents for detecting markers in cell targets, thus releasing users from difficult and tedious tasks (para. [0060]). This modification would have had a reasonable expectation of success given that both Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and Herzenberg et al. disclose methods requiring reagents for labeling and visualizing biological molecules.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and further in view of Bogh et al. (Methods and Applications in Fluorescence, 2015, Vol. 3, pp. 1-12, as cited in the Office action mailed 30 September 2024) in view of Levenson (Archives of Pathology & Laboratory Medicine, 2008, Vol. 132, pp. 748-757, as cited in the Office action mailed 30 September 2024).
Dependent claims 18 and 19 further define aspects of using machine learning to characterize data and further define characteristics of the types of information used in the calculation.
Bogh et al. discusses the importance of binding assays in biology and drug development, and shows that fluorescence technology is fast, easily automated, allows for parallel processing, and requires very small amounts of sample (p. 1, col. 2, para. 1).
Levenson discusses the history of spectral imaging and image analysis in the service of pathology.
Regarding dependent claims 18 and 19, Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, does not show the analyzer performs separation in accordance with a result of machine learning performed using the first fluorescence signal and the second fluorescence signal after the separation, the image information used in the separation, the information regarding the cell, and the information regarding the fluorescence reagent (claim 18); or the information regarding the fluorescence reagent includes a quantum yield, a fluorescent labeling ratio, and an absorption cross section or a molar absorption coefficient concerning the fluorescent reagent (claim 19); and the analyzer calculates at least one of the number of fluorescence molecules in the image information or the number of antibodies coupled to the fluorescence molecules using the image information from which the autofluorescence signal is removed and information regarding the fluorescence reagent (claim 19).
Regarding dependent claim 18, Levenson shows using spectral imaging and image analysis in pathology (Title) and shows that machine learning techniques can be used to teach systems to find regions and cellular compartments.
Regarding dependent claim 19, Levenson further shows a method to automate accurate tissue- and cell-based quantitation (page 751, column 1, para(s). 2 & 3; and Figures 12 & 13).
Regarding dependent claim 19, Bogh et al. shows techniques in methods and applications of fluorescence (Title; and Abstract), and further shows that high quantum yield in combination with a relatively low molar absorption coefficient are important considerations for fluorescence polarization-based measurements (page 2, column 1, para. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, by incorporating machine learning technology for automating tasks such as quantifying and segmenting biological characteristics of tissues examined using fluorescence analyses, as shown by Levenson, and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, with the methods of Levenson, because Levenson shows using machine learning techniques in spectral imaging and image analysis of pathology images. This modification would have had a reasonable expectation of success because both Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and Levenson show methods and imaging techniques for biological specimens.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, by incorporating information relevant to particular fluorescent dyes used as molecular probes, as shown by Boh et al., and discussed above. One of ordinary skill in the art would have been motivated to combine Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above with Bogh et al., because Bogh et al. shows a method that factors reagent-specific information such as the fluorescence quantum yield in combination with a relatively low molar absorption coefficient in fluorescence measurements. This modification would have had a reasonable expectation of success because both Levenson et al. and Croce et al. as applied to claims 1-4, 16, 20, 21, and 22 above, and Bogh et al. show using fluorescence imaging techniques for analysis of biological specimens.
Response to Arguments
The Applicant’s arguments/remarks received 13 February 2026 have been fully considered, however the Applicant does not provide arguments/remarks with regard to the rejections under 35 U.S.C. 103 in the Office action mailed 21 November 2025.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687
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